CBD for the Treatment of Alcohol Use Disorder

• Status: Recruiting
• Trial end date: 2022-05-31
• Target enrollment: 0
• Participant gender: All

Summary

This is a double-blind, placebo-controlled, parallel group study designed to assess the efficacy of full spectrum CBD and broad spectrum CBD, compared to a placebo control (PC), to reduce drinking in participants with moderate alcohol use disorder according to the DSM-V. If eligible for the study, subjects will be randomized to receive one of the conditions for 8 weeks.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Colorado, Denver
• Treatments: Cannabidiol; Epidiolex

Criteria

Inclusion Criteria:

1. Must be between 21-60 years old.

2. Meets Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-V) criteria for current Alcohol Use Disorder (AUD) of at least moderate severity (i.e., 4 or more DSM-V symptoms).

3. Currently seeking treatment for AUD.

4. If male, reports drinking, on average, at least 21 standard alcoholic drinks per week prior to screening; if female, reports drinking, on average, at least 14 standard drinks per week prior to screening.

5. Have at least one heavy drinking day (4 or more drinks per day for women/5 or more drinks per day for men) during the 7-day period prior to screening.

6. Live within 35 miles of the study site.

Exclusion Criteria:

1. Self-reported DSM-V diagnosis of any other substance use disorder.

2. Use nicotine daily.

3. Self-report use of cocaine, amphetamines, opioids, cannabis, or benzodiazepines in the last 30 days.

4. Report having or being treated for a current DSM-V Axis I diagnosis, including major depression, panic disorder, obsessive/compulsive disorder, post-traumatic stress disorder, bipolar affective disorder, schizophrenia, dissociative disorders, eating disorders, or any other psychotic or organic mental disorder.

5. Endorsing an item on the RMTS-S measure of suicide risk.

6. Currently taking any of the following medications:

1. Those known to have a major interaction with Epidiolex.

2. Acute treatment with any antiepileptic medications.

3. Medication known to affect alcohol intake (e.g., disulfiram, naltrexone, acamprosate, and/or topiramate).

7. Self-reported history of severe alcohol withdrawal (e.g., seizure, delirium tremens).

8. Clinically significant medical problems such as cardiovascular, renal, gastrointestinal, or endocrine problems that would impair participation or limit medication ingestion.

9. Current or past alcohol-related medical illness, such as gastrointestinal bleeding, pancreatitis, hepatocellular disease, or peptic ulcer.

10. Females of childbearing potential who are pregnant, nursing, or who are not using a reliable form of birth control.

11. Current charges pending for a violent crime (not including DUI-related offenses).

12. Lack of a stable living situation.